Multilayer helical wave filter for medical therapeutic or diagnostic applications

ABSTRACT

A multilayer helical wave filter having a primary resonance at a selected RF diagnostic or therapeutic frequency or frequency range, includes an elongated conductor forming at least a portion of an implantable medical lead. The elongated conductor includes a first helically wound segment having at least one planar surface, a first end and a second end, which forms a first inductive component, and a second helically wound segment having at least one planar surface, a first end and a second end, which forms a second inductive element. The first and second helically wound segments are wound in the same longitudinal direction and share a common longitudinal axis. Planar surfaces of the helically wound segments face one another, and a dielectric material is disposed between the facing planar surfaces of the helically wound segments and between adjacent coils of the helically wound segments, thereby forming a capacitance.

FIELD OF THE INVENTION

This invention generally relates to the problem of high frequency energyinduced onto implanted leads during medical diagnostic procedures suchas magnetic resonant imaging (MRI). More specifically, the presentinvention relates to an implantable medical system comprised of anactive medical device (AMD) and at least one lead extending exteriorlyfrom a proximal end at or adjacent to the AMD, to a biological sensingor stimulating electrode at a distal end. The lead has at least onemultilayer helical wave filter which is designed resonate at one or moreMRI RF pulsed frequencies. At resonance, the multilayer helical wavefilter presents a very high impedance in the lead system which impedesRF current flow thereby preventing overheating of the lead and/or itsdistal electrodes during exposure to high power radio frequency (RF)fields of a particular frequency and/or frequency range.

BACKGROUND OF THE INVENTION

The radio frequency (RF) pulsed field of an MRI scanner can couple to animplanted lead in such a way that electromagnetic forces (EMFs) areinduced in the lead. The amount of energy that is induced is related toa number of complex factors, but in general is dependent upon the localelectric field that is tangent to the lead and the integral of theelectric field strength along the lead. In certain situations, theseEMFs can cause RF currents to flow into distal electrodes or in theelectrode interface with body tissue. It has been documented that whenthis current becomes excessive, overheating of said lead or itsassociated electrode(s) or overheating of the associated interface withbody tissue can occur. There have been cases of damage to such bodytissue which has resulted in loss of capture of cardiac pacemakingpulses or tissue damage severe enough to result in brain damage ormultiple amputations, and the like.

Magnetic resonance imaging (MRI) is one of medicine's most valuablediagnostic tools. MRI is, of course, extensively used for imaging, butis also used for interventional medicine (surgery). In addition, MRI isused in real time to guide ablation catheters, neurostimulator tips,deep brain probes and the like. An absolute contra-indication forpacemaker or neurostimulator patients means that these patients areexcluded from MRI. This is particularly true of scans of the thorax andabdominal areas. Because of MRI's incredible value as a diagnostic toolfor imaging organs and other body tissues, many physicians simply takethe risk and go ahead and perform MRI on a pacemaker patient. Theliterature indicates a number of precautions that physicians should takein this case, including limiting the power of the MRI RF pulsed field(Specific Absorption Rate—SAR level), programming the pacemaker to fixedor asynchronous pacing mode, and then careful reprogramming andevaluation of the pacemaker and patient after the procedure is complete.There have been reports of latent problems with cardiac pacemakers orother AMDs after an MRI procedure, sometimes occurring many days later.Moreover, there are a number of papers that indicate that the SAR levelis not entirely predictive of the heating that would be found inimplanted leads or devices. For example, for magnetic resonance imagingdevices operating at the same magnetic field strength and also at thesame SAR level, considerable variations have been found relative toheating of implanted leads. It is speculated that SAR level alone is nota good predictor of whether or not an implanted device or its associatedlead system will overheat.

There has been some progress in the design of active medical devices forspecific use in an MRI environment under specified conditions. Forexample, Medtronic has received FDA approval for their REVO pacemaker,which is indicated at use for up to 2 watts per kilogram (Thorax scansexcluded). St. Jude Medical and Biotronik have also received conditionalapproval for MRI pacemakers in Europe.

There are three types of electromagnetic fields used in an MRI unit. Thefirst type is the main static magnetic field designated B₀ which is usedto align protons in body tissue. The field strength varies from 0.5 to3.0 Tesla in most of the commonly available MRI units in clinical use.Some of the newer research MRI system fields can go as high as 11.7Tesla.

The second type of field produced by magnetic resonance imaging is thepulsed RF field which is generated by the body coil or head coil. Thisis used to change the energy state of the protons and elicit MRI signalsfrom tissue. The RF field is homogeneous in the central region and hastwo main components: (1) the electric field which is circularlypolarized in the actual plane; and (2) the H field, sometimes generallyreferred to as the net magnetic field in matter, which is related to theelectric field by Maxwell's equations and is relatively uniform. Ingeneral, the RF field is switched on and off during measurements andusually has a frequency of 21 MHz to 64 MHz to 128 MHz depending uponthe static magnetic field strength. The frequency of the RF pulse forhydrogen scans varies by the Lamour equation with the field strength ofthe main static field where: RF PULSED FREQUENCY in MHz=(42.56) (STATICFIELD STRENGTH IN TESLA). There are also phosphorous and other types ofscanners wherein the Lamour equation would be different. One also has tobe concerned about harmonics that are produced by the MRI RF amplifierand birdcage coil of a typical MRI system. In addition to the main RFpulsed frequency, harmonics can also be deposited onto implanted leads.

The third type of electromagnetic field is the time-varying magneticgradient fields designated B_(X), B_(Y), B_(Z), which are used forspatial localization. These change their strength along differentorientations and operating frequencies on the order of 1 kHz. Thevectors of the magnetic field gradients in the X, Y and Z directions areproduced by three sets of orthogonally positioned coils and are switchedon only during the measurements.

At the frequencies of interest in MRI, RF energy can be absorbed by bodytissues (or elongated conductors) and converted to heat. The powerdeposited by RF pulses during MRI is complex and is dependent upon thepower (Specific Absorption Rate (SAR) Level) and duration of the RFpulse, the transmitted frequency, the number of RF pulses applied perunit time, and the type of configuration of the RF transmitter coilused. The amount of heating also depends upon the volume of tissueimaged, the electrical resistivity of tissue and the configuration ofthe anatomical region imaged. There are also a number of other variablesthat depend on the placement in the human body of the AMD and the lengthand trajectory of its associated lead(s). For example, it will make adifference how much EMF is induced into a pacemaker lead system as towhether it is a left or right pectoral implant. In addition, the routingof the lead and the lead length are also very critical as to the amountof induced current and heating that would occur.

The cause of heating in an MRI environment is twofold: (a) RF fieldcoupling to the lead can occur which induces significant local heating;and (b) currents induced between the distal tip and tissue during MRI RFpulse transmission sequences can cause local Ohms Law heating in tissuenext to the distal tip electrode of the implanted lead. The RF field ofan MRI scanner can produce enough energy to induce RF voltages in animplanted lead and resulting currents sufficient to damage some of theadjacent myocardial tissue. Tissue ablation (destruction resulting inscars) has also been observed. The effects of this heating are notreadily detectable by monitoring during the MRI. Indications thatheating has occurred would include an increase in pacing capturethreshold (PCT), venous ablation, Larynx or esophageal ablation,myocardial perforation and lead penetration, or even arrhythmias causedby scar tissue. Such long term heating effects of MRI have not been wellstudied yet for all types of AMD lead geometries. There can also belocalized heating problems associated with various types of electrodesin addition to tip electrodes. This includes ring electrodes or padelectrodes. Ring electrodes are commonly used with a wide variety ofimplanted device leads including cardiac pacemakers, andneurostimulators, and the like. Pad electrodes are very common inneurostimulator applications. For example, spinal cord stimulators ordeep brain stimulators can include a plurality of pad electrodes (forexample, 8.16 or 24 electrodes) to make contact with nerve tissue. Agood example of this also occurs in a cochlear implant. In a typicalcochlear implant there would be sixteen pad electrodes placed up intothe cochlea. Several of these pad electrodes make contact with auditorynerves.

Variations in the pacemaker lead length and implant trajectory cansignificantly affect how much heat is generated. A paper entitled,HEATING AROUND INTRAVASCULAR GUIDEWIRES BY RESONATING RF WAVES byKonings, et al., journal of Magnetic Resonance Imaging, Issue 12:79-85(2000), does an excellent job of explaining how the RF fields from MRIscanners can couple into implanted leads. The paper includes both atheoretical approach and actual temperature measurements. In aworst-case, they measured temperature rises of up to 74 degrees C. after30 seconds of scanning exposure. The contents of this paper areincorporated herein by reference.

The effect of an MRI system on the leads of pacemakers, ICDs,neurostimulators and the like, depends on various factors, including thestrength of the static magnetic field, the pulse sequence, the strengthof RF field, the anatomic region being imaged, and many other factors.Further complicating this is the fact that each patient's condition andphysiology is different and each lead implant has a different lengthand/or implant trajectory in body tissues. Most experts still concludethat MRI for the pacemaker patient should not be considered safe.

It is well known that many of the undesirable effects in an implantedlead system from MRI and other medical diagnostic procedures are relatedto undesirable induced EMFs in the lead system and/or RF currents in itsdistal tip (or ring) electrodes. This can lead to overheating of bodytissue at or adjacent to the distal tip.

Distal tip electrodes can be unipolar, bipolar, multipolar and the like.It is very important that excessive RF current not flow at the interfacebetween the lead distal tip electrode or electrodes and body tissue. Ina typical cardiac pacemaker, for example, the distal tip electrode canbe passive or of a screw-in helix type as will be more fully described.In any event, it is very important that excessive RF current not flow atthis junction between the distal tip electrode and, for example, intosurrounding cardiac or nerve tissue. Excessive current at the distalelectrode to tissue interface can cause excessive heating to the pointwhere tissue ablation or even perforation can occur. This can belife-threatening for cardiac patients. For neurostimulator patients,such as deep brain stimulator patients, thermal injury can causepermanent disability or even be life threatening. Similar issues existfor spinal cord stimulator patients, cochlear implant patients and thelike.

A very important and possibly life-saving solution is to be able tocontrol overheating of implanted leads during an MRI procedure. A noveland very effective approach to this is to first install parallelresonant inductor and capacitor bandstop filters at or near the distalelectrode of implanted leads. For cardiac pacemaker, these are typicallyknown as the tip and ring electrodes. One is referred to U.S. Pat. No.7,363,090; U.S. Pat. No. 7,945,322; U.S. Pat. No. 7,853,324; US2008/0049376 A1; U.S. Pat. No. 7,511,921; U.S. Pat. No. 7,899,551; andU.S. Pat. No. 7,853,325A1, the contents of all of which are incorporatedherein. U.S. Pat. No. 7,945,322 relates generally to L-C bandstop filterassemblies, particularly of the type used in active implantable medicaldevices (AIMDs) such as cardiac pacemakers, cardioverter defibrillators,neurostimulators and the like, which raise the impedance of internalelectronic or related wiring components of the medical device atselected frequencies in order to reduce or eliminate currents inducedfrom undesirable electromagnetic interference (EMI) signals.

Other types of component networks may also be used in implantable leadsto raise their impedance at MRI frequencies. For example, a seriesinductor may be used as a single element low pass filter. The inductancewill tend to look like a high impedance at high frequencies, such as theRF pulsed frequencies of a typical MRI scanner. For more information onthis refer to U.S. Pat. No. 5,217,010 (Tsitlik et al.), the contents ofwhich are incorporated herein by reference.

U.S. Pat. No. 7,363,090 and U.S. Pat. No. 7,945,322 show resonant L-Cbandstop filters placed at the distal tip and/or at various locationsalong the medical device leads or circuits. These L-C bandstop filtersinhibit or prevent current from circulating at selected frequencies ofthe medical therapeutic device. For example, for an MRI system operatingat 1.5 Tesla, the pulsed RF frequency is 63.84 MHz, as described by theLamour Equation for hydrogen. The L-C bandstop filter can be designed toresonate at or near 63.84 MHz and thus create a high impedance (ideallyan open circuit) in the lead system at that selected frequency. Forexample, the L-C bandstop filter when placed at the distal tip electrodeof a pacemaker lead will significantly reduce RF currents from flowingthrough the distal tip electrode and into body tissue. The L-C bandstopfilter also reduces EMI from flowing in the leads of a pacemaker therebyproviding added EMI protection to sensitive electronic circuits. Ingeneral, the problem associated with implanted leads is minimized whenthere is a bandstop filter placed at or adjacent to or within its distaltip electrodes.

At high RF frequencies, an implanted lead acts very much like an antennaand a transmission line. An inductance element disposed in the lead willchange its transmission line characteristics. The inductance can act asits own antenna pick-up mechanism in the lead and therefore, ideally,should be shielded. When one creates a very high impedance at the distalelectrode to tissue interface by installation of a resonant bandstopfilter as described in U.S. Pat. No. 7,038,900 and as further describedin U.S. Pat. No. 7,945,322, there is created an almost open circuitwhich is the equivalent of an unterminated transmission line. Thiscauses a reflection of MRI induced RF energy back towards the proximalend where the AIMD (for example, a pacemaker) is connected. In order tocompletely control the induced energy in an implanted lead, one musttake a system approach. In particular, a methodology is needed wherebyenergy can be dissipated from the lead system at the proximal end in away that does not cause overheating either at the distal electrodeinterface or at the proximal end cap. Maximizing energy transfer from animplanted lead is more thoroughly described in US 2010/0160997 A1, thecontents of which are incorporated herein by reference.

In order to work reliably, leads need to be stably located adjacent tothe tissue to be stimulated or monitored. One common mechanism foraccomplishing this has been the use of a fixation helix, which exits thedistal end of the lead and is screwed directly into the body tissue. Thehelix itself may serve as an electrode or it may serve as an anchoringmechanism to fix the position of an electrode mounted to, or forming aportion of the lead itself.

A problem associated with implanted leads is that they act as an antennaand tend to pick up stray electromagnetic signals from the surroundingenvironment. This is particularly problematic in an MRI environment,where the currents which are imposed on the leads can cause the leads toheat to the point where tissue damage is likely. Moreover, the currentsdeveloped in the leads during an MRI procedure can damage the sensitiveelectronics within the implantable medical device. Bandstop filters,such as those described in U.S. Pat. No. 7,363,090 and US 2011/0144734A1, reduce or eliminate the transmission of damaging frequencies alongthe leads while allowing the desired frequencies to pass efficientlythrough. Referring to U.S. Pat. No. 7,363,090, one can see that a simpleL-C bandstop filter can be realized using discrete passive electroniccomponents. This involves installing a capacitor in parallel with aninductor. As stated in U.S. Pat. No. 7,363,090 column 19, lines 59-65,“It is also possible to use a single inductive component that hassignificant parasitic capacitance between its adjacent turns. A carefuldesigner using multiple turns could create enough parasitic capacitancesuch that the coil becomes self-resonant at a predetermined frequency.In this case, the predetermined frequency would be the MRI pulsedfrequency.”

Several patents describe methods of constructing leads either withinductance or with inductance that has parasitic capacitance that formsbandstop filters. These include U.S. Pat. No. 5,217,010 and U.S. Pat.No. 7,561,906. Other publications that describe inductive structureswherein parasitic capacitors form bandstop filters are US 2006/0041294,US 2008/0243218, U.S. Pat. No. 7,917,213, US 2010/0174348, US2010/0318164, US 2011/0015713, US 2009/0281592, and US 2003/0144720.

Accordingly, there is a need for attenuating the RF energy that can beinduced onto or into an implanted lead system. Moreover, there is a needfor an implantable medical lead where the novel multilayer helical wavefilter design presents a high impedance at MRI RF pulsed frequencies andthereby prevents dangerous overheating of the leads and/or its distalelectrodes that are in contact with body tissue. The present inventionfulfills these needs and provides other related advantages.

SUMMARY OF THE INVENTION

The multilayer helical wave filter of the present invention has aprimary resonance at a selected RF therapeutic or diagnostic frequencyor frequency range and comprises an elongated conductor which may format least a portion of an implantable medical lead. At resonance, themultilayer helical wave filter provides a very high impedance at itsresonance frequency or frequencies. In this regard, even though itsequivalent circuit is more complex, the multilayer helical wave filterof the present invention performs in a similar manner to that of asimple bandstop filter consisting of a capacitor in parallel with aninductor. The elongated conductor that forms the multilayer helical wavefilter has at least one planar surface and includes a first helicallywound segment having a first end and a second end which forms a firstinductive component, a second helically wound segment having a first endand a second end which forms a second inductive component, and a thirdreturn connecting segment which extends substantially the length of thefirst and second helically wound segments to connect the second end ofthe first helically wound segment to the first end of the secondhelically wound segment. The first and second helically wound segmentsare wound in the same longitudinal direction and share a commonlongitudinal axis. The at least one planar surface of the firsthelically wound segment faces the at least one planar surface of thesecond helically wound segment, and a dielectric material is disposedbetween the facing planar surfaces of the first and second helicallywound segments and between adjacent coils of the first and secondhelically wound segments. Importantly, the direction of RF current flowwill be the same in both the first and second helically wound segments.

In preferred embodiments, the multilayer helical wave filters, whichconsist of first and second helically wound segments, are disposed at oradjacent to or within one or more distal electrodes. The electrode maycomprise the electrodes of cardiac pacemakers, such as a tip or a ringelectrode, and may be active (helix screw-in) or passive. Furthermore,the electrodes could be neurostimulator electrodes, including electrodeprobe bundles, pad electrodes, ring electrodes, nerve cuff electrodes,or the like.

Inductances created by the inductive components are electricallydisposed in parallel with parasitic capacitance between the first andthe second helically wound segments. Further, inductance formed by theinductive components is electrically disposed in parallel with parasiticcapacitance between facing planar surfaces of the first and secondhelically wound segments.

The elongated conductor may comprise a rectangular or a squarecross-sectional configuration. The dielectric material may comprise apolyimide, a liquid crystal polymer, PTFE, PEEK, ETFE, PFA, FEP,parylene, a dielectric polymer material, or titanium oxide. It is notnecessary to use only one dielectric type. In fact, an advantage of thepresent invention is that different dielectric materials may be used indifferent areas of the multilayer helical wave filter. For example, onecould use one type of dielectric with a specific dielectric constant,for a portion between the first and second helically wound segments, asecond dielectric with a different dielectric constant in anotherportion and even a third dielectric in different portion. This wouldchange the parasitic capacitance and the resonant characteristics of thevarious sections of the multilayer helical wave filter. In other words,the multilayer helical wave filter could be designed to be resonant at anumber of frequencies corresponding to various MRI RF pulsed frequenciesand/or their harmonics.

The return connecting segment may extend inside of both the first andsecond helically wound segments, or the return connecting segment mayextend exteriorly of both the first helically wound and second helicallywound segments. Further, the connecting segment may be coiled and againrouted either exteriorly of the first and second helically woundsegments, or inside of both the first and second helically woundsegments. The return connecting segment may be straight or curvilinear.Since the induced RF current is reversed in the return segment, it isimportant that the return connecting segment not be extended between thefirst helically wound segment and the second helically wound segment.

In various embodiments, one of the helically wound segments is disposedradially inside the other, or the first and second helically woundsegments are co-radially disposed about the common longitudinal axis ina side-by-side relationship.

In another embodiment, a third helically wound segment has a first endand a second end and forms a third inductive component. The first,second and third helically wound segments are wound in the samelongitudinal direction, wherein a planar surface of the third helicallywound segment faces a planar surface of the second helically woundsegment. The elongated conductor includes a second connecting segmentextending substantially the length of the second and third helicallywound segments to connect the second end of the second helically woundsegment to the first end of the third helically wound segment. Adielectric material is disposed between facing planar surfaces of thesecond and third helically wound segments.

In yet another embodiment of the multilayer helical wave filter of thepresent invention, a second elongated conductor is provided, which hasat least one planar surface and comprises (1) a first helically woundsegment having a first end and a second end and forming a firstinductive component, (2) a second helically wound segment having a firstend and a second end and forming a second inductive component, and (3) areturn connecting segment extending substantially the length of thefirst and second helically wound segments to connect the second end ofthe first helically wound segment to the first end of the secondhelically wound segment. The first and second helically wound segmentsare wound in the same longitudinal direction and share a commonlongitudinal axis, wherein the at least one planar surface of the firsthelically wound segment faces the at least one planar surface of thesecond helically wound segment. The return connecting segment providesthat current paths in first and second helically wound segments will bein the same direction. One or more dielectric materials are disposedbetween the facing planar surfaces of the first and second helicallywound segments, and between adjacent coils of the first and secondhelically wound segments. This second elongated conductor provides thatthe wave filter has both a first and a secondary primary resonance atselected MRI pulsed frequencies or frequency ranges.

The inductance created by the inductive components of the secondelongated conductor is electrically disposed in parallel with parasiticcapacitance between the first and the second helically wound segments.Moreover, the inductance formed by the inductive components of thesecond elongated conductor is electrically disposed in parallel withparasitic capacitance between facing planar surfaces of the first andsecond helically wound segments.

The elongated conductors are wound in the same longitudinal directionand share the same longitudinal axis, which means that the RF currentpaths in the elongated conductors of all helically wound segments are inthe same direction. The second elongated conductor further comprises arectangular or a square cross-sectional configuration.

The return connecting segment of the second elongated conductor extendswithin or exteriorly of both the first helically wound segment and thesecond helically wound segment. The return connecting segment of thesecond elongated conductor may further be coiled exteriorly orinteriorly of both the first and second helically wound segments.

In various configurations, one of the helically wound segments of thesecond elongated conductor may be disposed radially inside the other, orthe first and second helically wound segments of the second elongatedconductor may be co-radially disposed about the common longitudinal axisin a side-by-side relationship. One may also vary the pitch of thehelical winding of the first segment and/or the pitch of the secondsegment in order to vary the inductance and parasitic capacitance. Byvarying the pitch along the length of the multilayer helical wavefilter, one can create multiple resonances. For example, one couldcreate a resonance at the RF pulsed frequency of a 1.5 Tesla MRI scannerand also a second or even third resonance at its harmonics at 128 and192 MHz.

Preferably, the multilayer helical wave filter has a Q at resonancewherein the resultant 10 dB bandwidth is at least 10 KHz. In variousembodiments, the Q at resonance may be at least 100 KHz and in otherembodiments at least 0.5 MHz. By controlling the dielectric type, thedielectric constant of the dielectric material may be varied from 2 to50.

The primary resonance of the wave filter may comprise a plurality ofselective MRI RF pulsed frequencies or frequency ranges, and the wavefilter may resonate at the selected RF frequency or frequency range andalso at one or more of its harmonic frequencies.

The first helically wound segment may have a different cross-sectionalarea than the second helically wound segment. Moreover, the firsthelically wound segment may have a different number of turns than thesecond helically wound segment.

Electric insulation is typically provided for attenuating RF currentsand body fluids or tissues from degrading the impedance of the wavefilter at resonance. The insulation is typically continuous with anoverall insulation of the implantable medical lead, and may include aninsulative sleeve disposed about the elongated conductor.

Other features and advantages of the present invention will becomeapparent from the following more detailed description, taken inconjunction with the accompanying drawings which illustrate, by way ofexample, the principles of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate the invention. In such drawings:

FIG. 1 is a wire-formed diagram of a generic human body showing a numberof exemplary active medical devices (AMDs);

FIG. 2 illustrates an exemplary prior art cardiac pacemaker with theleads schematically shown extending to a patient's heart;

FIG. 3 is a schematic illustration of a prior art AMD with a bipolarlead;

FIG. 4 is similar to FIG. 3, except that the bipolar lead wires arecoaxially wound around one another;

FIG. 5 is an enlarged view of the area indicated by line 5-5 from FIG.4, illustrating wave filters associated with both the tip and ringelectrodes;

FIG. 6 illustrates a probe or catheter which has four distal electrodes;

FIG. 7 is an enlarged view of the distal tip section of the probe orcatheter of FIG. 6;

FIG. 8 is an isometric view of a multilayer helical wave filterembodying the present invention;

FIG. 9 is a partially schematic view of the structure shown in FIG. 8,wherein the first helically wound segment is much larger in diameterthan the second helically wound segment for illustrative purposes;

FIG. 10 is a sectional view taken generally along the line 10-10 fromFIG. 9;

FIG. 11 is an elevational view of the multilayer helical wave filter ofFIGS. 8 and 9 with end caps for convenient mechanical and electricalconnection into an implantable lead;

FIG. 12 is an electrical schematic diagram of the multilayer helicalwave filter of FIG. 11;

FIG. 13 is shows a structure similar to FIGS. 8-10, except that themultilayer helically wound wave filter includes a third helically woundinductor segment;

FIG. 14 is a sectional view taken generally along the line 14-14 fromFIG. 13;

FIG. 15 is an electrical schematic diagram of the multilayer helicalwave filter of FIGS. 13 and 14;

FIG. 16 is a graph of attenuation of the multilayer helical wave filterof FIGS. 13 and 14 versus frequency;

FIG. 17 is an enlarged sectional view taken of the area indicated byline 17-17 from FIG. 10;

FIG. 18 is a sectional view taken generally along line 18-18 from FIG.17, illustrating capacitance between adjacent helically wound segments;

FIG. 19 is a view similar to FIG. 17, wherein the adjacent helicallywound segments are round rather than rectangular;

FIG. 20 is a sectional view taken generally along line 20-20 and similarto FIG. 18, illustrating capacitance between adjacent wires;

FIG. 21 is similar to FIG. 8, but illustrates an alternative embodimentwherein adjacent inductive segments are aligned side-by-side;

FIG. 22 is an enlarged sectional view taken generally along line 22-22from FIG. 21;

FIG. 23 is a simplified P-Spice electrical schematic diagram of themultilayer helical wave filter shown in FIGS. 8-10;

FIG. 24 is a graph illustrating the frequency response of a 20-turncoaxial two-layer helical bandstop filter of the present invention;

FIG. 25 is a graph showing the frequency response for the multilayerhelical wave filter of FIGS. 8-10, which has been modified to showresonance through a frequency range corresponding to the RF pulsedfrequency for a 1.5 Tesla MRI scanner;

FIG. 26 is a Spectrum Analyzer scan taken from an RF probe locatedinside a 1.5 Tesla clinical MRI scanner;

FIG. 27 is an isometric view similar to FIG. 8, except that theconnecting segment has been curled around the outside of both the firstand second helically wound inductor segments;

FIG. 28 is side view of the structure shown in FIG. 27;

FIG. 29 is a sectional view taken generally along line 29-29 from FIG.28;

FIG. 30 is an elevational view of a unipolar pacemaker lead having aproximal connector with an embedded multilayer helical wave filter inaccordance with the present invention;

FIG. 31 is a schematic diagram of the unipolar lead of FIG. 30;

FIG. 32 is a view similar to FIG. 30, except that the multilayer helicalwave filter of the present invention is associated with the tip and ringelectrodes of an active fixation tip;

FIG. 33 is an electrical schematic diagram of the bi-polar activefixation electrode illustrated in FIG. 32;

FIG. 34 is an elevational view of the formation of three multilayerhelical wave filters wound about a common longitudinal axis;

FIG. 35 is a sectional view taken generally along line 35-35 from FIG.34;

FIG. 36 is an electrical schematic illustration of the structure shownin FIGS. 34 and 35;

FIG. 37 is an elevational view of an 8-pin paddle electrode;

FIG. 38 is an elevational view of the reverse side of the paddleelectrode shown in FIG. 37;

FIG. 39 is an enlarged sectional view taken generally of the areaindicated by line 39-39 from FIG. 37;

FIG. 40 is an elevational view of another embodiment for a multilayerhelical wave filter embodying the present invention, wherein threereturn conductors are provided to perform two discrete multilayerhelical wave filters that are in series with each other;

FIG. 41 is a schematic diagram of the multilayer helical wave filter ofFIG. 40;

FIG. 42 is a schematic illustration showing that any number ofindividual multilayer helical wave filters can be placed in series inany conductor of any implanted lead;

FIG. 43 is an elevational view of the multilayer helical wave filter ofFIG. 11 shown in series with a passive fixation electrode and animplanted lead.

FIG. 44 is a schematic diagram which illustrates undesirable electricalleakage through body fluids in parallel with the multilayer helical wavefilter of FIG. 43.

FIG. 45 is an elevational view of the multilayer helical wave filter ofFIG. 43 with electrical insulation disposed over the multilayer helicalwave filter such that electrical leakage through body fluids isprevented.

FIG. 46 is a sectional view of an active fixation electrode assemblyembodying a multilayer helical wave filter with seals to prevent ingressof body fluids.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As shown in the drawings for purposes of illustration, the presentinvention relates to multilayer helical wave filters placed betweenproximal and distal ends of an implantable lead of an active medicaldevice (AMD). One or more multilayer helical wave filters may beimplanted anywhere along the length of implanted leads or electrodes ofAMDs. In particular, the multilayer helical wave filter of the presentinvention presents a very high impedance (which impedes RF current flow)at one or more MRI RF pulsed frequencies. The present invention isparticularly important to protect implanted leads from overheating inthe presence of high power electromagnetic field environments, such asthe RF pulsed fields produced by a clinical MRI scanner. In a broadsense, the present invention comprises a multilayer helical wave filterwhich is installed in one or more locations along the length of theconductors of an implanted lead. As will be shown, it is also veryimportant that the multilayer helical wave filter be insulated along itsentire length with insulation integral to the implanted lead so that RFleakage paths do not occur around the filter through ionic body fluids.

The multilayer helical wave filter of the present invention acts as animpeding circuit. The operation of impeding circuits and diversioncircuits is more thoroughly described in U.S. Pat. No. 7,751,903 and US2010/0160997 A1, which are incorporated herein by reference. In aparticularly preferred embodiment, the multilayer helical wave filterhas a Q and 3-dB bandwidth such that, at resonance, it offersattenuation of at least 10-dB over a range of MRI RF pulsed frequenciesat least 10 kHz wide, and more preferably at least 100 kHz or even onthe order of MHz. The novel multilayer helical wave filter of thepresent invention can be used in combination with any of the diversioncircuits as described in U.S. Pat. No. 7,751,903 and US 2010/0160997 A1.

In the case where a multilayer helical wave filter is installed at ornear the distal electrode of an implanted lead, the RF energy induced bythe MRI pulse field is inhibited from flowing into body tissues.However, even when a distal electrode multilayer helical wave filter isused, the induced RF energy still resides in the lead system. In otherwords, by preventing this induced energy from flowing to sensitivetissues at distal electrode interfaces, a great deal has beenaccomplished; however, it is still important to carefully dissipate theremaining energy that is trapped in the lead system. Dissipation of theRF energy that's reflected off of a distal tip electrode filter is morethoroughly described in US 2010/0217262 A1 which is incorporated hereinby reference. US 2010/0217262 reference teaches how to dissipate energyto the relatively large surface area of the AIMD housing thereby safelyremoving it from the lead system.

FIG. 1 is a wire formed diagram of a generic human body showing a numberof exemplary implantable medical devices. 100A is a family ofimplantable hearing devices which can include the group of cochlearimplants, piezoelectric sound bridge transducers and the like. 100Bincludes an entire variety of neurostimulators and brain stimulators.100C shows a cardiac pacemaker. 100D includes the family of leftventricular assist devices (LVAD's) and artificial hearts. 100E includesan entire family of drug pumps which can be used for dispensing ofinsulin, chemotherapy drugs, pain medications and the like. 100Fincludes a variety of implantable bone growth stimulators for rapidhealing of fractures. 100G includes urinary incontinence devices. 100Hincludes the family of pain relief spinal cord stimulators andanti-tremor stimulators. 100I includes a family of implantablecardioverter defibrillator (ICD) devices, congestive heart failuredevices (CHF), and cardio resynchronization therapy devices, otherwiseknown as CRT devices. 100 j illustrates a family of probes or cathetersthat can be transvenously inserted during catheter lab procedures. Theseare normally considered short-term implants in that they are insertedwithin the human body for at most a few hours. 100K is an externallyworn active medical device, such as a neurostimulator. It can be worn ona belt, placed in a pocket or the like. Typically, it has one or moreimplanted leads. 100K also represents an externally worn drug pump orthe like.

The various types of active medical devices (AMDs) illustrated in FIG. 1generally represent any type of AMD that is either a “long-term” or“short-term” implant. “Short-term” implants include AMDs like probes orcatheters or surgical devices that are “short-term” body insertions usedeither for diagnostic or therapy delivery purposes. For example, a probeor catheter is typically used in a cath-lab situation wherein it istemporarily inserted through a femoral (or other) artery where theentire procedure lasts minutes or at most a few hours. On the otherhand, a long-term implant, such as a cardiac pacemaker, is generallydesigned to be implanted in the human body for many years. There aresignificant differences in the art between a short-term and a long-termimplant. For example, for a long-term implant, one has to worry greatlyabout the long-term biocompatibility, toxicity and even the hermeticityof the implant. In contrast, a probe, catheter or temporary looprecorder need only operate or be reliable for a matter of minutes oreven hours. In general, a short-term implant is often considered to be adisposable device. In addition, the FDA regulatory approval processesfor long-term implants is significantly different and involves much morerigorous testing and product safety and reliability criteria. The FDACenter for Devices and Radiological Health (FDA-CDRH) is the responsibleregulatory agency for long-term cardiac implants. As used herein, theterm active medical device (AMD) or active implantable medical device(AIMD) is construed to include long-term implants and also short-termbody insertions, such as probes or catheters. The term AMD is inclusiveof active implantable medical devices (AIMDs) and also externally wornmedical devices that are associated with an implanted lead.

Throughout, the term lead generally refers to implantable leads andtheir conductors that are external to the housing of the active medicaldevice. These leads tend to have a proximal end, which is at or adjacentto the AMD, and a distal end, which typically includes one or moreelectrodes which are in contact with body tissue.

FIG. 2 is a drawing of a typical cardiac pacemaker 100C showing atitanium case or housing 102 and an IS-1 header connector block 104. Thetitanium case or housing 102 is hermetically sealed, however there is apoint where leadwires 106 a-106 d must ingress and egress a hermeticseal. This is accomplished by providing a hermetic terminal assembly 108that generally consists of a ferrule 110 which is laser welded to thetitanium housing 102 of the pacemaker 100C.

Four leadwires are shown consisting of leadwire pair 106 a and 106 b andleadwire pair 106 c and 106 d. This is typical of what is known as adual chamber bipolar cardiac pacemaker. The IS-1 connectors 112 and 112′of leads 114 and 114′ are designed to plug into receptacles 116 and 116′in the header block 104. The receptacles 116 and 116′ are low voltage(pacemaker) connectors covered by an ANSI/AAMI ISO standard IS-1. Highervoltage devices, such as implantable cardioverter defibrillators (ICDs),are covered by ANSI/AAMI ISO standard DF-1. A new standard which willintegrate both high voltage and low voltage connectors into a miniaturein-line quadripolar connector is known as the IS-4 series. The implantedleads 114 and 114′ are typically routed transvenously in a pacemakerapplication down into the right atrium 118 and the right ventricle 118′of the heart 120. New generation biventricular or CRT-P devices mayintroduce leads to the outside of the left ventricle, which devices haveproven to be very effective in cardiac resynchronization and treatingcongestive heart failure (CHF).

Although the present invention will be described herein in the contextand environment of a cardiac pacemaker 100C and its associated leads 114and 114′, the present invention may also be advantageously utilized inmany other types of AMDs as briefly outlined above and shown in FIG. 1,as well as in other commercial electronic, military, aerospace and otherapplications. In the following discussion, to the extent practicable,functionally equivalent components will retain the same or a similarreference number, irrespective of the particular embodiment beingdescribed.

FIG. 3 illustrates a prior art single chamber bipolar AMD 100C and leadsystem 114 and 114′ with a distal tip electrode 122 and a ring electrode124 typically as used with a cardiac pacemaker 100C. Should the patientbe exposed to the fields of an MRI scanner or other powerful emitterused during a medical diagnostic procedure, currents that are directlyinduced in the lead system 114, 114′ can cause heating by I²R losses inthe lead system or by heating caused by RF current flowing from the tipand ring electrodes 122, 124 into body tissue. If these induced RFcurrents become excessive, the associated heating can cause damage oreven destructive ablation to body tissue.

FIG. 4 illustrates a single chamber bipolar cardiac pacemaker 100C, andleads 114 and 114′ having distal tip 122 and distal ring 124 electrodes.This is a spiral wound (coaxial) system where the ring coil 114′ iswrapped around the tip coil 114. There are other types of pacemakerleadwire systems in which these two leads lay parallel to one another(known as a bifilar lead system), which are not shown.

FIG. 5 is taken from section 5-5 of FIG. 4, and shows multilayer helicalwave filters 126 a and 126 b. As illustrated, there is a multilayerhelical wave filter 126 a of the present invention at or adjacent to thetip electrode 122 also a multilayer helical wave filter 126 b at thering electrode 124. In general, the multilayer helical wave filters 126,would be tuned to be resonant at a center frequency in a range of MRI RFpulsed frequencies. The operation of simple L-C bandstop filters inimplanted leads is more thoroughly described by U.S. Pat. No. 7,363,090and U.S. Pat. No. 7,945,322. The performance of the multilayer helicalwave filter 126 of the present invention is similar to that of a simpleL-C bandstop filter, except that its equivalent circuit diagram is muchmore complicated. In addition, unlike a simple L-C bandstop filter, themultilayer helical wave filter can be designed with multiple resonancesas described herein. It is useful to think of these multiple resonancesas equivalent to multiple bandstop filters of varying resonantfrequencies that are disposed in series with the implanted lead.

FIG. 6 illustrates a probe or a catheter 100 j which has four internalconductors 132 a-132 d which are directed to four different distalelectrodes 134 a-134 d at its distal end. In the art, electrode 134 dwould be known as an ablation electrode wherein the other electrodescould be used for cardiac electrical mapping and the like. The probe orcatheter 100 j encompasses multilayer helical wave filters 126 a-126 dof the present invention in series with each of the conductors that aredirected to the electrodes 134 a-134 d. The probe or catheter 100 jconsists of a flexible and steerable probe or catheter section 136 whichmay be bent as shown and generally terminates in the distal electrodes134 a-134 d. There is generally a catheter handle or body 138 which isused for steering the probe or catheter into the body transvenously.These handles can take the form of a pistol grip or many other shapes.

FIG. 7 is a sectional view taken generally along section 7-7 from FIG.6. Shown are the four conductors 132 a-132 d which are housed inside theprobe or catheter steerable body 136. There are four multilayer helicalwave filter 126 a-126 d in accordance with the present invention. Eachof these multilayer helical wave filters 126 is in series with one ofthe distal electrodes 134. These multilayer helical wave filters 126impede MRI RF induced currents from flowing into the electrodes 134 andthereby inadvertently overheating and damaging adjacent living tissues.

FIG. 8 is an isometric view of a multilayer helical wave filter 126 ofthe present invention which is in series with an implanted lead (notshown). Also not shown is an overall insulation covering the multilayerhelical wave filter which is contiguous with the implanted lead toprovide isolation of the multilayer helical wave filter from bodyfluids. This insulation is omitted for clarity purposes in many of thedrawings, however, it will be understood that this insulation isessential so that the impedance of the multilayer helical wave filter atresonance is not degraded by parallel RF current paths through bodytissues. Shown is an elongated rectangular conductor 140 with an MRI RFinduced current i_((t)) shown entering it. The elongated conductor 140forms a first helically wound inductor segment 142. Then there is areturn wire connecting segment 144 (which could be coiled) which is usedto wind a second helically wound inductor 146 inside of the firstsegment. Accordingly, the first helically wound inductor segment 142 andthe second helically wound inductor segment 146 are wound in the samelongitudinal direction and share a common longitudinal axis where planarsurfaces of the first helically wound segment 142 face or abut planarsurfaces of the second helically wound inductor segment 146. In general,the elongated conductor has a dielectric insulation which may also beused to insulate the entire multilayer helical wave filter such that RFcurrent through body fluids do not degrade its impedance at resonance. Acapacitance is therefore formed between the planar surfaces of the firsthelically wound inductor segment 142 and the second helically woundinductor segment 146. There is also a capacitance that is formed betweenadjacent turns. The effect of these inductor segments and capacitanceswill be to form a helical wave filter 126 in accordance with the presentinvention. There are a number of advantages to the multilayer helicalwave filter construction as illustrated in FIG. 8. First of all, byusing biocompatible materials, there is no need for discrete componentsplaced inside of a hermetic seal. One is referred to US 2010/0231237 fora description of how discrete passive capacitors and inductors areplaced inside a hermetically sealed housing to form a bandstop filter.This package is both large and very expensive to produce. It will beapparent that the multilayer helical wave filter 126 of the presentinvention is both volumetrically efficient and relatively much lower incost.

FIG. 9 is very similar to FIG. 8 except that the first helically woundsegment 142 is much larger in diameter than the second helically woundinductor segment 146. This is to better illustrate the principles of thepresent invention and also indicate the direction of current flow. Asone can see, in both the first (outer) helical wound inductor segment142 and the second (inner) helically wound inductor segment 146, the RFinduced current flow from MRI is always in the same direction. Havingthe current flow be in the same direction of the various inductorsegments of the present invention is critically important and a majordistinguishing feature over the prior art. Having the RF current flow inthe same direction increases the inductance by up to a factor of fourtimes as compared to having a single inductor winding. Current flow inthe same direction results in much stronger effective fields as opposedto field reduction in the case of opposite current flows in adjacentturns. The design of the return wire or segment 144, which can bestraight, curvilinear or coiled, (and also be either external orinternal to the inductor segments) is a key. In the prior art, whichteaches parasitic inductance to form simple bandstop filters, thecurrent flow of adjacent coils is generally in opposite directions(reference Bottomley US 2008/0243218 A1). In the present invention, thefields associated with the return wire or segments 144 are negligible incomparison with the fields generated by both the inner and outermultilayer helical inductor segments 142 and 146.

Referring once again to FIG. 8, one could also vary the pitch betweenadjacent turns of portions of the multilayer helical wound wave filter126. This would create sections that had a different resonant frequencyas compared to other sections. Accordingly, it is a feature of thepresent invention that the multilayer helical wave filter 126 can beresonant at 1, 2 or even “n” number of selected RF frequencies. Similareffects can be achieved by carefully controlling the overlap areabetween the planar surfaces of the outer inductor segment 142 and theinner inductor segment 146. This would affect the amount of parasiticcapacitance and hence the resonant frequency. It is also possible tocontrol this parasitic capacitance by controlling the dielectricthickness or the dielectric type in various sections of the multilayerhelical wave filter 126 of the present invention. By controlling thedielectric type, the dielectric constant can be varied anywhere from twoto fifty. Most polymer-type dielectric coatings have a dielectricconstant that fall between two and four. However, there are certainother types of dielectrics such as tantalum oxide, which would providesignificantly higher dielectric constants (closer to 40). Differentmaterials with different dielectric constants can be used in differentsections of the multilayer helical wave filter.

In FIG. 8, one can see that the return wire or segment 144 is directedthrough the inside of both the first helically wound inductor segment142 and the second helically wound inductor segment 146. FIG. 9 shows analternate configuration wherein the return wire or segment 144 returnsoutside of both the first helically wound inductor segment 142 and thesecond helically wound inductor segment 146. In both FIG. 8 and FIG. 9,this return wire or connecting segment 144 is a straight elongatedconductor. As will be shown in subsequent drawings, it will also bepossible to coil this conductor 144 to increase mechanical flexibilityof the filtered region. It is advised that the number of coils in thisreturn path be limited to the minimum number of turns needed. This is toensure that the eddy currents created by this return path (reversecurrents) will be minimal and should not greatly impact the overallinductance of the first and second helical wound segments. Typically,the coiled return path is disposed at an angle to the first and secondhelically wound segments. This is to reduce the effect of eddy currentsdue to reverse currents in the return path [ideally close to 90 degreesis better but it could be anywhere greater than 0 degrees except (n*pi)n being 0, 1, 2, etc.]. This coiled return path is also useful inincreasing or controlling the phase shift between the RF inducedcurrents in the first helically wound inductor segment 142 relative tothe currents in the second helically wound inductor segment 146.

FIG. 10 is taken along section 10-10 from FIG. 9 and shows the elongatedconductor 140 that forms the first helically wound inductor segment 142and the second helically wound inductor segment 146 in cross-section. Acapacitance 148 is formed between each of the coplanar surfaces betweenthe first helically wound inductor 142 and the second helically woundinductor 146. In addition, there is a parasitic capacitance 150 that isformed between adjacent turns of both the first helically wound inductor142 and the second helically wound inductor segments 146. The firsthelically wound inductor 142 and the second helically wound inductor 146along with capacitance 148 and 150 form a multilayer helical wave filterin accordance with the present invention. By carefully adjusting theinductance and capacitance values, one can design the filter to resonateand provide a very high impedance at one or more selected MRI RFfrequencies.

FIG. 11 illustrates the multilayer helical wave filter previouslyillustrated in FIGS. 8 and 9 with end caps 152 and 154 for convenientmechanical and electrical connection in series into one or moreconductors of an implantable lead of an AIMD. For example, animplantable lead 114 may be comprised of material MP35N. The leadconductor would be easily laser welded to mandrel end cap 156 of 152.The multilayer helical wave filter of the present invention is disposedbetween these two end caps. End cap 154 is shown connected to a distalelectrode in contact with body tissues. The multilayer helical wavefilter 126 of the present invention can be disposed anywhere along thelength of an implanted lead. However, in a particularly preferredembodiment, it is disposed at or near the distal electrode. An electrodeassembly (not shown) may be electrically and mechanically connected toend cap 154.

FIG. 12 is a schematic diagram showing the multilayer helical wavefilter 126 disposed between the two end caps 152 and 154. The end capsare shown attached in the implantable lead 114 with one end directed tothe AMD and the other end directed to electrode 122. Multiple discretemultilayer helical wave filters may be installed in series anywherealong the length of the implanted lead as well. An overall electricalinsulation 158 is integral to the lead 114 and also surrounds both endcaps 152 and 154 in the entire multilayer helical wave filter 126. Thisinsulation is very important to prevent RF electrical leakage throughbody fluids in parallel with the multilayer helical wave filter 126.Such RF leakage currents can significantly degrade the impedance of themultilayer helical wave filter at its one or more resonant frequencies.The amount of RF current leakage can be so severe that the multilayerhelical wave filter becomes ineffective in preventing a distal electrodefrom overheating during an MRI scan.

FIG. 13 is very similar to FIGS. 8, 9 and 10 except that it additionallyhas a third helically wound inductor segment 160. In this case, thereare two return connecting segments 144 and 144′. All three of thehelically wound inductor segments 142, 146 and 160 have facing planarsurfaces in which capacitances 148 are formed. In addition, there areparasitic capacitances 150 between the turns of each one of the first,second and third helically wound inductor segments. The structure ofFIG. 13 is useful to form multiple resonances to provide a highimpedance and therefore a high degree of attenuation to various MRI RFpulsed frequencies. For example, typical 1.5 Tesla scanners operate atan RF pulsed frequency of approximately 64 MHz. 3.0 Tesla scanners arebecoming more common and operate at 128 MHz RF pulsed frequency. Byhaving a multilayer helical wave filter 126 that provides a resonance atboth these frequencies, the implanted lead system can provide a highdegree of immunity to overheating from both the 1.5 and 3-Tesla systems.Accordingly, the multilayer helical wave filter can be designed to beresonant at a first, second or even “n” selected RF frequencies.

FIG. 14 is a sectional view taken from section 14-14 from FIG. 13. Thethree helically wound inductor segments 142, 146 and 160 are clearlyshown. One could use the same dielectric material to coat all threehelically wound segments or use different dielectric materials. Forexample, one could use one dielectric material between the first andsecond inductor segments and a second dielectric material between thesecond and third helically wound segments. This would create a differentparasitic capacitance and thereby a different resonant frequency. Theresult is a multilayer helical wave filter 126 which could be designedto be resonant at a number of selected MRI RF pulsed frequencies. Ingeneral, the resonant frequency of each segment is approximated by theequation:

$f_{r} = \frac{1}{2\pi \sqrt{LC}}$

Where f_(r) is the resonant frequency, L is the inductance, in Henries,of the inductor component, and C is the capacitance, in Farads, of thecapacitor component. In this equation, there are three variables: f_(r),L, and C. The resonant frequency, f_(r), is a function of the MRI systemof interest. As previously discussed, a 1.5T MRI system utilizes an RFsystem operating at approximately 64 MHz, a 3.0T system utilizes a 128MHz RF, and so on. By determining the MRI system of interest, only L andC remain. By first selecting one of these two variable parameters, afilter designer needs only to solve for the remaining variable. Note,for a more accurate prediction of resonant frequency f_(r), the PSPICEcircuit of FIG. 23 should be used.

FIG. 15 is the schematic diagram of the multilayer helical wave filterof FIGS. 13 and 14 illustrating that the wave filter has multipleresonances at fr₁ and fr₂. For example, the multilayer helical wavefilter 126 can be designed to be resonant at both 64 MHz (1.5-Tesla MRI)and 128 MHz (3-Tesla MRI). Accordingly, this would provide a very highimpedance in the implanted lead during patient exposure to either one ofthese commonly available MRI scanners.

FIG. 16 is a graph of attenuation of the multilayer helical wave filter126 of FIGS. 13 and 14 versus frequency in MHz. As one can see, there isa resonant peak at both fr₁ and fr₂ corresponding to 64 MHz and 128 MHz.In both cases, the impedance of the multilayer helical wave filter 126is quite high which results in an attenuation value exceeding 10-dB. Ingeneral, the attenuation would be measured on a Spectrum Analyzer in abalanced 50-ohm system.

FIG. 17 is taken generally along section 17-17 from FIG. 10. Shown isthe end view of the elongated conductor that forms the first helicallywound inductor segment 142 and the second helically wound inductorsegment 146. One can see that in the preferred embodiment, the outer orfirst helically wound inductor segment 142 is wound very tightly to thesecond helically wound inductor segment 146. Preferably, there is littleto no air gap in between. In addition, there is a dielectric orinsulative coating 162 on the elongated conductor(s). This dielectriccoating 162 is very important for two reasons: (1) it prevents adjacentturns from shorting and also prevents the first helically wound inductorsegment 142 from shorting to the second helically wound inductor segment146; and (2) the dielectric coating material has a much higherdielectric constant than air, thereby allowing one to increase or tunethe capacitances 148 and 150.

FIG. 18 is taken generally along section 18-18 from FIG. 17. Thecapacitance 148 is shown. As previously described, the first helicallywound inductor 142 would be wound tightly to the second helically woundinductor 146. However, in FIG. 18, they are shown separated forconvenience so one can show the schematic symbol for the capacitor 148.The amount of parasitic capacitance 148 is determined by the overlaparea of the outer helix segment and the inner helix segment. One canincrease the amount of capacitance by increasing the width of theelongated conductors 142 and 146. The capacitance value is also relatedto the dielectric constant of the insulating material 162 and also thedielectric thickness of the insulting material 162. Reducing thedielectric thickness increases the capacitance value significantly.These relationships are expressed ideally by the following equation:

${C = \frac{n\; \kappa \; A}{t}},$

where n is the number of overlapping capacitance areas, k is thedielectric constant of the insulating material, A is the effectivecapacitance area and t is the thickness between opposing plates. For theoverlapping faces of the inner and outer segments of a multilayerhelical wave filter, the effective capacitance area is relatively largesince it includes the entire overlap area. This gives the designer manydegrees of freedom in selecting the primary parasitic capacitance value148.

FIG. 19 is substantially the same as FIG. 17, except that the conductoris no longer rectangular or square in cross-section. The conductor shownin FIG. 19 would be a conventional round wire which would be highlyundesirable in the present invention. As shown in FIG. 20, the effectivecapacitance (ECA) overlap area would be very small. Not only would theresulting capacitance be very small, but it would also be highlyvariable. As one can see, any slight variations in winding or windingalignment would cause the capacitance value of 148 to vary dramatically.Accordingly, it is a feature of the present invention that the elongatedconductor 140 that forms the multilayer helical wave filter 126 be ofeither rectangular or square wire, preferably coated in a dielectricfilm 154 or the like. The size and shape of the elongated conductor thatforms the helically wound segments is important. In general, a square orrectangular cross-section is preferred. By controlling the geometryand/or width of the elongated conductor that overlaps between theadjacent first helical segment and the second helical segment, one cancontrol the parasitic capacitance that is formed. In other words, thedesigner can control the resonant frequency by controlling both theinductance and the amount of parasitic capacitance that is formed.Importantly, the designer can also control the Q and resulting 3-dBbandwidth at resonance of the multilayer helical wave filter. Theprimary factor in controlling the Q is to control the resistance of thewire that forms the first helical segment and the second helicalsegment. The resistivity of the wire is one of its primary materialproperties. One can choose from various materials to form the elongatedconductor and the first and second helical segments. The resistance isalso determined by the overall length of the elongated conductor of thefirst and second helical segments and also inversely related to itscross-sectional area (width times height). One also controls theparasitic capacitance by proper selection of the type of dielectriccoating, the dielectric thickness and/or the distance between the innerand outer segments. This can be used to control second, third of even nresonant frequencies as well. A primary determining factor of theparasitic capacitance is the effective capacitance area which isdetermined by the amount of planar surface overlap between the firsthelically wound segment and the second helically wound segment. Thefirst, second and third inductor segments can all be of the samecross-sectional shape and area elongated conductors and of the samenumber of turns. However, each segment could also have a differentcross-sectional area of conductor and even a different number of turns.This affords the designer many degrees of freedom in controlling theinductance, resonant frequency and the Q of each resonant section.

There are several ways to apply the dielectric coating 154. One waywould be to coat the entire elongated conductor wire 140 before formingthe first and second helically wound inductor segments 142 and 146.Another way to do this would be through carefully controlled windingprocesses where the entire assembly was subsequently dipped or subjectedto vacuum deposited dielectric material such as parylene. In anotherembodiment, a dielectric film could be disposed between the firsthelically wound inductor segment 142 and the second helically woundinductor segment 146. There are various suitable dielectric insulativematerials such as Polyimide, aromatic polyimide, liquid crystal polymer,PTFE, PEEK, ETFE, Parylene, tantalum oxides, any nano-dielectriccoating, PFA, FEP, Polyurethane, polyurethane with self-bondingovercoat, polyamide, polyvinyl acetal, polyvinyl acetal overcoated withpolyamide, polyurethane overcoated with polyamide, epoxy, polyester(amide) (imide) overcoated with polyamide, polyester (amide) (imide),silicone-treated glass fiber, polyamide-imide, thermoplastic compounds,polyvinylchloride (PVC), polyolefin class: {LDPE, HDPE, TPO, TPR,polyolefin alloys}, LDPE low density, HDPE high density, polypropylene(PP), thermoplastic fluoropolymers, TEFLON FEP, Tefzel ETFE, Kynar PVDF,TEFLON PFA, Halar ECTFE, PTFE Teflon, PTFE Teflon film, XLPE & XLPVC,silicone rubber, Polyimide Kapton film, Polyester Mylar film, KaladexPEN film, crosslinked polyalkene, and various other types of polymer orceramic materials. Different dielectric materials may be used fordifferent sections of the multilayer helical wave filter. This would beto create different capacitance values and different resonance sections.

FIG. 21 illustrates an alternative construction of the multilayerhelical wave filter 126 of the present invention. Referring back toFIGS. 8 and 9, one can see that the second helically wound inductorsegment 146 is wound inside of the first helically wound inductorsegment 142 on the same longitudinal axis. In FIG. 21, by way ofcontrast, one can see that the first helically wound inductor segment142 and the second helically wound inductor segment 146 are woundadjacent to each other side-by-side along the same longitudinal axis.There is still a return wire 144 in order to make sure that thedirection of turns of both the first helically wound inductor 142 andthe second helically wound inductor 146 are in the same direction sothat the RF currents are in the same direction as described inconnection with FIGS. 8 and 9.

FIG. 22 is taken generally along section 22-22 from FIG. 21. This showsthe elongated conductor 140 of the first helically wound inductorsegment 142 alongside the elongated conductor forming the secondhelically wound inductor segment 146. As can be seen, there is acapacitance 150 that is formed between the coils of the first helicallywound inductor 142 and the second helically wound inductor 146 segments.

FIG. 23 is a simplified P-Spice schematic diagram of the multilayerhelical wave filter 126 shown in FIGS. 8, 9 and 10. The voltage sourceshown in FIG. 18 would be the voltage induced in an implanted lead by amedical diagnostic procedure, such as by the RF field of an MRI scanner.The load resistance R is shown for simplification and would actually bea complex impedance based on the impedance of the lead system, bodytissues and the input impedance of the active medical device (AMD).Those skilled in the art will understand that the capacitances andinductances and resistances of FIG. 23 would be distributed throughoutthe length of the multilayer helical wave filter 126. They are shown aslumped elements for simplicity. In FIG. 23, one can see the firsthelically wound inductor segment 142 consisting of L1 and resistance R1.The second helically wound inductor segment 146 is shown as inductanceL2 and resistance R2. The resistance values R1 and R2 are determined bythe classical resistance of any conductor wherein the resistance isproportional to the conductivity Rho (times) the length L (divided by)cross-sectional area A. The 3 dB bandwidth of the resonance of themultilayer helical wave filter 126 is determined by its Q at resonance.The Q is defined as the frequency of resonance (divided by) the changein (delta) 3 dB bandwidth Q=f_(r)/Δf_(3 dB). For a more completedescription on this subject, one is referred to U.S. Pat. No. 7,363,090and US 2011/0144734. As previously described, by controlling theinductance and capacitance of different sections, the multilayer helicalwave filter 126 can be designed to have multiple resonances at differentfrequencies. Interestingly, one could also vary either the conductor 140cross sectional area, material or length in different sections whichwould result in a different Q and 3-dB bandwidth at each resonantfrequency. As one can see, the novel multilayer helical wave filter 126affords the designer many opportunities to attenuate the current flow ofone or multiple RF frequencies.

FIG. 24 is the frequency response of a 20 turn coaxial 2-layer helicalwave filter 126 showing a resonant peak at 144 MHz. The cross-sectionalarea of the elongated conductor that forms the multilayer helical wavefilter segments can vary in width anywhere from 0.0005 inches to 0.025inches. The height of the rectangular square wire can also vary anywherefrom 0.0005 inches to 0.025 inches. If the elongated conductor is round,the diameter can vary anywhere from 0.0010 to 0.025. The multilayerhelical wave filter can be particularly designed for cardiac leads,wherein the diameter is typically anywhere from 2 French to 9 French(0.090 inches for 7 French or for neuro leads of 0.052 inches indiameter, which are typically 1 French. In general, the multilayerhelical wave filter of the present invention can be built in any sizefrom 1 French and above. Shown are the real part, the imaginary part andthe absolute values of the impedance. One can also control theresistance R1 and R2 of the multilayer helical wave filter by properconductor material selection. Biocompatible materials include MP35N,stainless steel and all of its alloys, tantalum, or drawn filled tubes.Drawn filled tubes can have a core of silver, gold, platinum or the likewith an outer coating or tubing of MP35N, stainless steel 316LVN,nitinol or the like. Accordingly, one can control the inductance, thecapacitance and the resistance of each segment of the multilayer helicalwave filter individually. The resistance will largely determine the Qand the 3-dB bandwidth at each resonance point.

FIG. 25 shows the helical wave filter 126 of FIG. 8 and FIG. 9 has beenmodified to show the inductance and the capacitance values 148 and 150such that the multilayer helical wave filter is resonant at 64 MHz,which corresponds to the RF pulsed frequency for 1.5 Tesla MRI scanners.As can be seen on the left vertical axis, the impedance Z is plotted inkilohms. On the right vertical axis, the phase angle is plotted indegrees. One can see that there is a phase shift from positive tonegative that corresponds with the resonant center frequency of 64 MHz.Markers 1 and 2 shown on the impedance curve correspond with frequenciesf₁ and f₂. These are the 3-dB down points. The 3-dB bandwidth ispreferably 10 kHz or greater and is the difference in frequency off₂−f₁. The 3-dB bandwidth would be best measured in a Spectrum orNetwork analyzer in a balanced 50 ohm system measuring attenuation. Onecan see that the multilayer helical wave filter 126 of the presentinvention provides over 1000 ohms (1 kilohm) of impedance at the MRI RFpulsed frequency. This provides a dramatic amount of attenuation andcurrent reduction thereby preventing implanted leads and/or theirassociated electrodes from overheating during an MR scan. Optimalselection of materials and dielectrics can provide up to 5 to 10 kilohmsof impedance at resonance. As previously mentioned, in order to providethis high impedance at resonance, it is critical that the multilayerhelically bandstop filter be insulated such that RF currents cannotconduct around it through body fluids or tissues thereby degrading theimpedance through these parallel paths.

FIG. 26 is a Spectrum Analyzer scan taken from an RF probe locatedinside a 1.5 Tesla clinical MRI scanner. The primary RF pulsed frequencyis shown as marker 1 as 64 MHz. The harmonics of the RF pulsed frequencyare generally not specified or controlled by manufacturer specificationsor industry standards. In other words, these harmonics are largelyuncontrolled. The scan shows a harmonic (marker 2) at 128 MHz, aharmonic (marker 3) at 192 MHz, a harmonic (marker 4) at 256 MHz andeven a harmonic at 320 MHz (marker 5). The primary RF pulsed frequency(64 MHz) and its harmonics can all contribute to RF currents in a leadand particularly RF currents at a distal electrode to tissue interface.Accordingly, the primary frequency and its harmonics can all contributeto leadwire heating.

The multilayer helical wave filter can be designed to have resonances atthe primary MRI RF frequency (64 MHz) and also at some or all of itsharmonic frequencies. In general, only harmonics of significantamplitude would require attenuation by the multilayer helical wavefilter.

FIG. 27 is similar to FIG. 8 except that the connecting segment 144 hasbeen coiled around the outside of both the first helically woundinductor 142 and second helically wound inductor 146 segments. Coilingof the return wire 144 decreases its inductance and increases itscapacitance. By changing the inductance of the return wire 144, onecontrols the phase shift between the RF currents in various segments aspreviously described. This can be used to introduce a secondaryresonance into the multilayer helical wave filter 126 in such a way toprovide attenuation at multiple MRI RF pulsed frequencies. For example,attenuation could be provided at both 64 MHz (1.5 Tesla) and 128 MHz (3Tesla). It will be obvious to one skilled in the art that the multilayerhelical wave filter can be designed to have one, two, three orn-resonant frequencies.

FIG. 28 is the side view of the multilayer helical wave filter 126 shownin FIG. 27.

FIG. 29 is a sectional view taken generally along line 29-29 from FIG.28. Shown is the elongated conductor 140 of the first helical woundsegment 142, the second helically wound segment 146 and the connectingsegment 144. A coiled return wire 144 could be applied to any of thepreviously described multilayer helical wave filters 126 such as shownin FIG. 8, 9, 13 or 21.

FIG. 30 illustrates a unipolar pacemaker lead 164 having a proximalconnector 166 such as described by International Standards ISO-IS1, DF1,DF4 or IS4. This proximal connector 166 would be plugged into a cardiacpacemaker, a cardioverter defibrillator or the like (not shown). Thedistal end of the lead has a tip electrode 122 with tines 168 which areused to grasp trabecular or other tissue within a human heart. Shown isa multilayer helical wave filter 126 of the present invention that islocated near or at the distal unipolar electrode 122. Referring onceagain to FIG. 30, one can see that the lead body has an overallinsulation 158 which extends over the multilayer helical wave filter toa point near the distal electrode 122. This insulation is criticallyimportant to prevent RF currents from circulating through the bodyfluids thereby tending to short out or degrade the impedance of themultilayer helical wave filter 126. In a preferred embodiment, theoverall insulation 158 still provides that the center of the multilayerhelical wave filter can be hollow for convenient guide wire insertion.In addition, the center of the wave filter could incorporate one or morevalves such that additional leads or guide wires placed from theproximal side can be routed and sealed. Access from the distal sidewould be restricted in a similar manner to a hemostasis valve in anintroducer. As previously described, when exposed to an MRI highintensity RF environment, the multilayer helical wave filter 126 impedesthe undesirable flow of RF currents into body tissues via electrode 122.Referring once again to FIG. 30, one can see that the lead body has anoverall insulation 158 which extends over the multilayer helical wavefilter to a point near the distal electrode 122. This insulation iscritically important to prevent RF currents from circulating throughbody fluids thereby tending to short out or degrade the impedance of themultilayer helical wave filter 126. Thereby the multilayer helical wavefilter 126 prevents overheating of the distal electrode 122 and/or thesurrounding body tissues. It has been shown, that overheating of saidtissues can cause changes in pacemaker capture threshold or evencomplete loss of pacing.

FIG. 31 is a schematic diagram of the unipolar lead 164 of FIG. 30showing the AMD 100C and a multilayer helical wave filter 126 of thepresent invention installed preferably at or near the distal tipelectrode 122.

FIG. 32 is very similar to FIG. 30 except a bi-polar active fixationelectrode 170 is shown at the distal end or tip of the implanted lead.In this case, the screw-in helix tip electrode 122 has been extended,which would typically be screwed into cardiac tissue. A ring electrode124 forms a bi-polar electrode system wherein pacing and sensing can beconducted between the helix tip electrode 122 and the ring electrode124. There would be two conductors 114 and 114′ in this case that wouldbe routed to and plugged into the active medical device. There is amultilayer helical wave filter 126 a in series with the helix electrode122 and also a multilayer helical electrode 126 b in series with thering electrode 124. In this way, both the distal helix 122 and ringelectrodes 124 would both be prevented from overheating in an MRIenvironment. Insulation 158 prevents RF currents from flowing throughbody fluids and shorting out multilayer helical wave filter 126 a andinsulation material 158′ insulates multilayer helical wave filter 126 band performs the same function. In addition, the insulating layer 158also protects the implanted lead, provides flexibility and lubricity andaids in the long-term reliability of the overall lead system.

FIG. 33 is the schematic diagram of the bi-polar lead previouslyillustrated in FIG. 32. One can see the active implantable medicaldevice such as a cardiac pacemaker 100C with implanted lead conductors114 and 114′. Lead conductor 114 is directed in series with a multilayerhelical wave filter of the present invention to ring electrode 124. Leadconductor 114′ has multilayer helical wave filter 126 a in series withtip electrode 122. As previously described, in preferred embodiments,the multilayer helical wave filter 126 a and 126 b are very near or atthe respective distal electrodes. This prevents RF current inductionfrom MRI fields from coupling around the wave filters and inducingcurrents in the distal electrodes.

FIG. 34 illustrates the formation of three multilayer helical wavefilters 126 a, 126 b and 126 c of the present invention. As shown inFIG. 36, these could be split out to be placed in series with threedifferent electrodes 122 a, 122 b and 122 c. This arrangement isparticularly advantageous for neurostimulator applications where theremight be 3, 6, 12, 16, 24 or even “n” electrodes. Accordingly,multilayer helical wave filters 126 can be wound to be in series withany number of such electrodes (n-electrodes). Any number (m) of these“n” multilayer helical wave filters can also be used in a neuro leadwherein the number of electrodes becomes =n=m. In other words, a neuroelectrode matrix can be easily formed by the multilayer helical wavefilter of the present invention.

FIG. 35 is a sectional view of the three electrode configurationsillustrated in FIG. 34. The filter region consists of three multilayerhelical wave filters of the present invention. That, in turn, isconnected to the implanted lead. Electrodes 122 a, 122 b and 122 c aretypically the ring or pad electrodes of a neural lead.

FIG. 36 is the schematic diagram of the three electrode multilayerhelical wave filter of FIG. 35. Shown are three multilayer helical wavefilter segments 126 a, 126 b and 126 c shown in series with each of thethree ring or paddles electrodes 122 a, 122 b and 122 c. Each of theconductors of the implanted lead 114 a, 114 b and 114 c are shownconnected to the active implantable medical device 100C.

FIG. 37 illustrates an 8-pin paddle electrode 172 commonly used inspinal cord stimulator applications. The eight paddle electrodes areshown as 176 a through 176 h.

FIG. 38 is the reverse side of the paddle electrode 172 of FIG. 37.

FIG. 39 is a cross-section taken generally from section 39-39 from FIG.37. One can see that there is a multilayer helical wave filter 126 inseries with each one of the pad electrodes 176. FIG. 39 is just arepresentative example. As used herein, electrodes shall include anytype of electrode in contact with body tissue. This includes, but is notlimited to, pacemaker electrodes, endocardial electrodes, epicardialelectrodes, defibrillator shocking coils, tip electrodes, ringelectrodes, ablation electrodes, deep brain electrodes, nerve cuffelectrodes, various types of paddle electrodes, cochlear electrodebundles, Bions, probe and catheter electrodes and the like.

FIG. 40 is a special multilayer helical wave filter with three returnconductors 144 a, 144 b and 144 c which form two discrete multilayerhelical wave filters 126 a and 126 b that are in series with each other.In accordance with the present invention, each one would have a selectedRF resonant frequency. In a preferred embodiment, the first resonantfrequency f_(r1) would be the RF pulsed frequency of a 1.5-Tesla commonMRI scanner at 64 MHz. The second multilayer helical wave filter portionwould be resonant f_(rz) at 128 MHz which is the RF pulsed frequency forcommonly available 3-Tesla MR scanners. By varying the cross-sectionalarea of the elongated conductor and also the pitch and number of turns,in addition to the dielectric material and separation between the innerand outer coils, the resonant frequencies f_(r1) and f_(r2) can beprecisely tuned.

FIG. 41 is a schematic diagram of the multilayer helical wave filter ofFIG. 40 showing that it provides (in one package) for two resonances inseries which are shown as f_(r1) and f_(r2).

FIG. 42 illustrates that any number of individual or separate discretemultilayer helical wave filters 126 can be placed in series in anyconductor of any implanted lead in multiple locations along the leadlength. For example, referring once again to FIG. 8, three differenthelical wave filters could be placed in series along the length of animplanted lead as shown. In FIG. 42, there are three different helicalwave filters that are resonant at f_(r1), f_(r2) and f_(r3). It will beobvious to those skilled in the art that any number of helical wavefilters can be placed in series in an implanted lead. In summary,multiple resonances fr₁ and fr₂ . . . or fr_(n) can be created bymultiple segments in a single multilayer helical wave filter or multipleresonances can also be achieved by installing a multiplicity of discretewave filters along the length of the lead as shown in FIG. 42.

FIG. 43 illustrates the multilayer helical wave filter 126 with end caps152 and 154 that were previously illustrated in FIG. 11. End cap 152 isshown attached to the conductor 114 of an implanted lead 158 which hasan overall insulation sheath 158. In this case, by way of example, themultilayer helical wave filter 126 presents 2000 ohms at its primaryresonant frequency of 64 MHz. However, in this configuration, since themultilayer helical wave filter is not have overall end to endinsulation, there are undesirable RF leakage pads L₁ and L₂ through bodytissue. The 2000 ohms of impedance desirably impedes the flow of MRIinduced RF currents into body tissue through the electrode 122. However,if both ends of the multilayer helical wave filter are not isolated fromeach other, parallel paths result through body fluid (ionic fluid). Thisparallel path as measured by the inventors can be approximately 80 ohms.Referring back to FIG. 43, if an 80 ohms parallel path existed betweenthe end caps 152 and 154, this would seriously degrade the impedance atresonance. The amount of degradation in impedance can result in RFcurrents flowing through the distal electrode 122 into body tissues thatcould result in life-threatening overheating of these adjacent tissues.

FIG. 44 is the schematic diagram taken from FIG. 43 showing the 2000-ohmimpedance Z_(F) of the multilayer helical wave filter 126. Shown inparallel with the multilayer helical wave filter 126 is the leakage pathor 80-ohm impedance of the body tissues Z_(L). Using the parallelresistance formula, when one has 80 ohms in parallel with 2000 ohms, theresult is a combined impedance Z_(TOT) of 76.82 ohms. As one can see,this is a catastrophic reduction of the impedance of the multilayerhelical wave filter at resonance. It is a critical feature of thepresent invention that these body fluid paths be insulated so that theycannot cause leakage in parallel with the multilayer helical wave filterof the present invention.

FIG. 45 is very similar to FIG. 43 except that the lead insulation 158′has been extended completely over the multilayer helical wave filter 126of the present invention. Accordingly, the leakage paths through ionicbody fluid L₁ and L₂ have been eliminated. In this case, the multilayerhelical wave filter of FIG. 45 would present the full 2000 ohms ofimpedance at the MRI RF-pulsed frequency.

FIG. 46 illustrates an active fixation helix tip electrode assemblytypically used in cardiac pacemaker applications. Shown is a multilayerhelical wave filter 126 of the present invention. In this case, themultilayer helical wave filter is shown in a hermetic subassembly 180.Electrically isolating electric components in a medical electric leadwith an active fixation electrode are described in US 2010/0324240 (seeFIG. 10) the contents of which are incorporated herein.

FIG. 46 illustrates an exemplary bipolar active fixation electrode 170which embodies a lead body 178, a coaxial conductor 114′ for the ringelectrode 124 and coaxial conductor 114 for the tip (active fixationhelix) electrode 122, a collar 180, and the translatable casing 182which houses a multilayer helical wave filter 126 of the presentinvention. The translatable casing 182 includes a pins 152 and 154. Thepin 152 is electrically and mechanically connected to the tip electrodelead wire conductor 114 and the pin 154 is attached to the translatableseal assembly 184 which is also connected to a distal helix electrode122. The distal helix electrode 122 is also known as an active fixationelectrode. The pin 152, the casing 182, the pin 154 and the translatableseal structure 184 all form what is defined herein as a casingsubassembly 186. A casing 182 which houses the multilayer helical wavefilter 126 can be a hermetic seal as previously described in FIG. 10 orUS 2010/0324640 or it can be a rigid or semi-rigid subassembly similarto that previously illustrated in FIG. 11 herein. As previouslydescribed, it is very important that body fluids be prevented fromencroaching across the two ends 152 and 154 of casing 182 and themultilayer helical wave filter 126. As previously described, theseparallel ionic conduction paths can seriously degrade the impedance ofthe wave filter at resonance.

Referring once again to FIG. 46, there will typically be a laser weld(not shown) electrically and mechanically connecting the tip conductor114 to pin 152. There is also a laser weld 188 connecting pin 154 to aweld sleeve 190 of the translatable seal assembly 184. The weld sleeve190 may be attached to the pin 154 in any known technique includinglaser welding, bonding, crimping, adhering, brazing, other forms ofwelding, or any other suitable method. The weld sleeve 190 is typicallylaser welded to the helix electrode 122. During transvenous insertion,the active fixation helix tip electrode 122 is retracted (as shown) sothat it will not inadvertently stab or poke into body tissues duringlead insertion. When the physician has positioned it in the desirablelocation (perhaps inside the cardiac right ventricle), then thephysician takes a special tool and twists the proximal end of lead body178 tip conductor 114 which causes the entire conductor 114 and casingsubassembly 182 to rotate. As the distal helix electrode 122 rotates, itengages a guide 192 which causes the helix 122 to extend and screw intobody tissue. The guide 192 may be formed as part of the collar 180 andengages the tip electrode 122 when the tip conductor 114 is rotated. Therotation causes the helical tip electrode 122 to rotate within thecollar 180 and thereby translate in a forward manner. At the same timethe tip electrode 122 is advancing relative to the collar 180, it isengaging with body tissue by being screwed directly into the tissueforming an attachment. The tip electrode 122 can be rotated in theopposite direction by the tip conductor 114 and thereby disengaged fromthe tissue for removal and/or reattachment at a different location. Thisis a method of active affixation which is well known in the art.

The flexible seal 194 of FIG. 46 slides against the interior of thecollar 180 thereby preventing the entrance of ionic body fluids into theinside of the lead body 178. The seal 194 may be bonded, molded,adhered, or formed onto the weld sleeve 190 by any suitable means. Theseal 194 can be formed in a multitude of ways appreciated by thoseskilled in the art, such as multiple wipers, o-rings, thin disks orsheets, and various molded profiles.

There is a secondary optional O-ring seal 196 as shown in FIG. 46. Theoptional O-ring seal 196 is disposed between the inside diameter of thelead collar 180 and the outside diameter of the translatable housing andmultilayer helical wave filter 126. The purpose of seal 194 and theO-ring seal 196 is to ensure that ionic body fluids cannot be disposedacross the important electrical path between pins 152 and 154. Ionicbody fluids can represent an undesirable parallel path as low as 80ohms. Over time, due to bulk permeability, body fluids will penetrateinto the interior of the lead body 178. However, this is an osmotic typeof action. The resulting fluids that would occur over long periods oftime inside the lead body 178 would be distilled and free of ioniccontaminants (de-ionized). This means that they would be less conductiveof high frequency electrical signals from one end to the other of themultilayer helical wave filter 182, 126. The presence of optional O-ring196 is desirable in that it also presents a high impedance to such aparallel circuit path. The casing 182,126 may also have a conformalinsulative coating (not shown) for further electrically isolatingterminals 152 and 154 such that a parallel path through body fluid isfurther impeded. The insulative coating may be formed from any suitablematerial, such as a dielectric material, including, but not limited toparylene, ETFE, PTFE, polyamide, polyurethane and silicone. It will beunderstood that the exemplary embodiment of FIG. 46 may work with orwithout such coatings. The casing 182 may be a metallic and hermeticallycontainer or any biocompatible insulative material. The multilayerhelical waver filter of the present invention is hollow on the insidefor convenient insertion of additional wires.

From the foregoing it will be appreciated that, the multilayer helicalwave or bandstop filters 126 of the present invention resonate at one ormore frequencies and thereby provide a very high impedance at a selectedresonant frequency(ies) or range of frequencies, and comprises anelongated conductor 140 having at least one planar surface. Theelongated conductor includes a first helically wound segment 142 havinga first end and a second end forming a first inductor component, areturn wire or return coil 144, and a second helically wound segment 146having a first end and a second end forming a second inductor component.The first and second helically wound segments share a commonlongitudinal axis and are wound in the same direction wherein inducedcurrents also flow in the same direction. The return wire or return coil144 extends substantially to the length of the first and secondhelically wound inductor segments to connect the second end of the firsthelically wound segment to the first end of the second helically woundsegment.

The planar surface or surfaces of the first inductor faces the planarsurface or surfaces of the second inductor and are coated with adielectric insulative layer. Parasitic capacitance is formed between theplanar surfaces of both the inner and outer inductors and adjacentcoils. The combination of the inductors and the parasitic capacitancesform a multi-helical wave filter, which in preferred embodiments act asa bandstop filter. By providing a very high impedance at MRI pulsedfrequencies, the multilayer helical wave filter of the present inventionprevents the leadwire and/or its distal electrodes that are in contactwith body tissue from overheating.

Although several embodiments of the invention have been described indetail for purposes of illustration, various modifications of each maybe made without departing from the spirit and scope of the invention.Accordingly, the invention is not to be limited, except as by theappended claims.

1. A multilayer helical wave filter for an implantable lead of an activemedical device, comprising: an elongated conductor, including: a firsthelically wound segment having at least one planar surface, a first endand a second end, the first helically wound segment forming a firstinductive component; a second helically wound segment having at leastone planar surface, a first end and a second end, the second helicallywound segment forming a second inductive component, the first and secondhelically wound segments being wound in the same longitudinal directionand sharing a common longitudinal axis, wherein the at least one planarsurface of the first helically wound segment faces the at least oneplanar surface of the second helically wound segment; and a returnconnecting segment extending substantially the length of the first andsecond helically wound segments to connect the second end of the firsthelically wound segment to the first end of the second helically woundsegment; and a dielectric material disposed between the facing planarsurfaces of the first and second helically wound segments, and betweenadjacent coils of the first and second helically wound segments, therebyforming a capacitance; wherein the wave filter has a primary resonanceat a selected RF diagnostic or therapeutic frequency or frequency range.2. The multilayer helical wave filter of claim 1, further comprising: asecond elongated conductor, including: a first helically wound segmenthaving at least one planar surface, a first end and a second end, thefirst helically wound segment forming a first inductive component; asecond helically wound segment having at least one planar surface, afirst end and a second end, the second helically wound segment forming asecond inductive component, the first and second helically woundsegments being wound in the same longitudinal direction and sharing acommon longitudinal axis, wherein the at least one planar surface of thefirst helically wound segment faces the at least one planar surface ofthe second helically wound segment; and a return connecting segmentextending substantially the length of the first and second helicallywound segments to connect the second end of the first helically woundsegment to the first end of the second helically wound segment; and adielectric material disposed between the facing planar surfaces of thefirst and second helically wound segments, thereby forming a firstcapacitance, and between adjacent coils of the first and secondhelically wound segments, thereby forming a second capacitance; whereinthe second elongated conductor provides a wave filter with a secondprimary resonance at a selected RF diagnostic or therapeutic frequencyor frequency range.
 3. The multilayer helical wave filter of claim 1,wherein the return connecting segment provides that induced RF currentpaths in the first and second helically wound segments will be in thesame direction.
 4. The multilayer helical wave filter of claim 1,including a dielectric material coating over all surfaces or sides ofthe elongated conductor.
 5. The multilayer helical wave filter of claim1, wherein the inductance created by the inductive components iselectrically disposed in parallel with the capacitance between the firstand the second helically wound segments.
 6. The multilayer helical wavefilter of claim 5, wherein inductance formed by the inductive componentsis electrically disposed in parallel with the capacitance between facingplanar surfaces of the first and second helically wound segments.
 7. Themultilayer helical wave filter of claim 1, wherein the first and secondhelically wound segments are disposed at or adjacent to or within a tipelectrode, a ring electrode, a paddle electrode or a catheter electrode.8. The multilayer helical wave filter of claim 7, wherein the electrodeincludes an active fixation tip or a passive electrode tip.
 9. Themultilayer helical wave filter of claim 1, wherein the selected RFdiagnostic or therapeutic frequency or frequency range comprises one ormore MRI RF pulsed frequencies or frequency ranges.
 10. The multilayerhelical wave filter of claim 1, wherein the return connecting segmentextends within or exteriorly of the first helically wound segment andthe second helically wound segment.
 11. The multilayer helical wavefilter of claim 1, wherein the return connecting segment is coiledexteriorly or interiorly of the first and second helically woundsegments.
 12. The multilayer helical wave filter of claim 1, wherein oneof the helically wound segments is disposed radially inside the other.13. The multilayer helical wave filter of claim 1, wherein the first andsecond helically wound segments are co-radially disposed about thecommon longitudinal axis in a side-by-side relationship.
 14. Themultilayer helical wave filter of claim 1, wherein the elongatedconductor comprises a rectangular or square cross-sectionalconfiguration.
 15. The multilayer helical wave filter of claim 1,wherein the dielectric material comprises polyimide, aromatic polyimide,liquid crystal polymer, PTFE, PEEK, ETFE, Parylene, tantalum oxides, anynano-dielectric coating, PFA, FEP, Polyurethane, polyurethane withself-bonding overcoat, polyamide, polyvinyl acetal, polyvinyl acetalovercoated with polyamide, polyurethane overcoated with polyamide,epoxy, polyester (amide) (imide) overcoated with polyamide, polyester(amide) (imide), silicone-treated glass fiber, polyamide-imide,thermoplastic compounds, polyvinylchloride (PVC), polylefin class:{LDPE, HDPE, TPO, TPR, polyolefin alloys}, LDPE low density, HDPE highdensity, polypropylene (PP), thermoplastic fluoropolymers, TEFLON FEP,Tefzel ETFE, Kynar PVDF, TEFLON PFA, Halar ECTFE, PTFE Teflon, PTFETeflon film, XLPE & XLPVC, silicone rubber, Polyimide Kapton film,Polyester Mylar film, Kaladex PEN film, or a crosslinked polyalkene. 16.The multilayer helical wave filter of claim 1, including a thirdhelically wound segment having a first end and a second end and forminga third inductive component, the first, second and third helically woundsegments being wound in the same longitudinal direction, wherein aplanar surface of the third helically wound segment faces a planarsurface of the second helically wound segment, and wherein the elongatedconductor includes a second return connecting segment extendingsubstantially the length of the second and third helically woundsegments to connect the second end of the second helically wound segmentto the first end of the third helically wound segment, and includingdielectric material disposed between facing planar surfaces of thesecond and third helically wound segments.
 17. The multilayer helicalwave filter of claim 1, wherein the wave filter has a Q at resonancewherein the resultant 10 dB bandwidth is at least 10 KHz.
 18. Themultilayer helical wave filter of claim 17, wherein the wave filter hasa Q at resonance wherein the resultant 10 dB bandwidth is at least 100kHz.
 19. The multilayer helical wave filter of claim 18, wherein thewave filter has a Q at resonance wherein the resultant 10 dB bandwidthis on the order of megahertz and at least 0.5 MHz.
 20. The multilayerhelical wave filter of claim 1, wherein by controlling the dielectrictype, the dielectric constant of the dielectric material may be variedfrom 2 to
 50. 21. The multilayer helical wave filter of claim 1, whereinthe primary resonance of the wave filter comprises a plurality ofselected MRI RF pulsed frequencies or frequency ranges.
 22. Themultilayer helical wave filter of claim 1, wherein the wave filterresonates at the selected RF frequency or frequency range and also atone or more of its harmonic frequencies.
 23. The multilayer helical wavefilter of claim 1, wherein the first helically wound segment has adifferent cross-sectional area than the second helically wound segment.24. The multilayer helical wave filter of claim 23, wherein the firsthelically wound segment has a different number of turns than the secondhelically wound segment.
 25. The multilayer helical wave filter of claim1, including electrical insulation for attenuating RF currents in bodyfluids or tissues from degrading the impedance of the wave filter atresonance.
 26. The wave filter of claim 25, wherein the insulation iscontiguous with an overall insulation of the implantable lead.
 27. Themultilayer helical wave filter of claim 25, including an electricallyinsulative sleeve disposed about the elongated conductor.
 28. Amultilayer helical wave filter, comprising: an elongated conductor,including: a first helically wound segment having at least one planarsurface, a first end and a second end, the first helically wound segmentforming a first inductive component; a second helically wound segmenthaving at least one planar surface, a first end and a second end, thesecond helically wound segment forming a second inductive component, thefirst and second helically wound segments being wound in the samelongitudinal direction and sharing a common longitudinal axis, whereinthe at least one planar surface of the first helically wound segmentfaces the at least one planar surface of the second helically woundsegment; and a return connecting segment extending substantially thelength of the first and second helically wound segments to connect thesecond end of the first helically wound segment to the first end of thesecond helically wound segment; and a dielectric material disposedbetween the facing planar surfaces of the first and second helicallywound segments, and between adjacent coils of the first and secondhelically wound segments, thereby forming a capacitance; wherein thewave filter has a primary resonance at a selected RF frequency orfrequency range.
 29. The multilayer helical wave filter of claim 28,wherein the return connecting segment provides that induced RF currentpaths in the first and second helically wound segments will be in thesame direction.
 30. The multilayer helical wave filter of claim 28,including a dielectric material coating over all surfaces or sides ofthe elongated conductor.
 31. The multilayer helical wave filter of claim28, wherein inductance created by the inductive components iselectrically disposed in parallel with the capacitance between the firstand the second helically wound segments.
 32. The multilayer helical wavefilter of claim 28, wherein inductance formed by the inductivecomponents is electrically disposed in parallel with the capacitancebetween facing planar surfaces of the first and second helically woundsegments.
 33. The multilayer helical wave filter of claim 28, whereinthe first and second helically wound segments are disposed at oradjacent or within to a tip electrode, a ring electrode, a paddleelectrode or a catheter electrode.
 34. The multilayer helical wavefilter of claim 28, wherein the electrode includes an active fixationtip or a passive electrode tip.
 35. The multilayer helical wave filterof claim 28, wherein the selected RF frequency or frequency rangecomprises one or more MRI RF pulsed frequencies or frequency ranges. 36.The multilayer helical wave filter of claim 28, wherein the returnconnecting segment extends entirely within or exteriorly of the firsthelically wound segment and the second helically wound segment.
 37. Themultilayer helical wave filter of claim 36, wherein the returnconnecting segment is coiled exteriorly or interiorly of the first andsecond helically wound segments.
 38. The multilayer helical wave filterof claim 28, wherein one of the helically wound segments is disposedradially inside the other.
 39. The multilayer helical wave filter ofclaim 28, wherein the respective first and second helically woundsegments are co-radially disposed about the common longitudinal axis ina side-by-side relationship.
 40. The multilayer helical wave filter ofclaim 28, wherein the elongated conductor comprises a rectangular orsquare cross-sectional configuration.
 41. The multilayer helical wavefilter of claim 28, wherein the dielectric material comprises polyimide,aromatic polyimide, liquid crystal polymer, PTFE, PEEK, ETFE, Parylene,tantalum oxides, any nano-dielectric coating, PFA, FEP, Polyurethane,polyurethane with self-bonding overcoat, polyamide, polyvinyl acetal,polyvinyl acetal overcoated with polyamide, polyurethane overcoated withpolyamide, epoxy, polyester (amide) (imide) overcoated with polyamide,polyester (amide) (imide), silicone-treated glass fiber,polyamide-imide, thermoplastic compounds, polyvinylchloride (PVC),polylefin class: {LDPE, HDPE, TPO, TPR, polyolefin alloys}, LDPE lowdensity, HDPE high density, polypropylene (PP), thermoplasticfluoropolymers, TEFLON FEP, Tefzel ETFE, Kynar PVDF, TEFLON PFA, HalarECTFE, PTFE Teflon, PTFE Teflon film, XLPE & XLPVC, silicone rubber,Polyimide Kapton film, Polyester Mylar film, Kaladex PEN film, or acrosslinked polyalkene.
 42. The multilayer helical wave filter of claim30, including a third helically wound segment having a first end and asecond end and forming a third inductive component, the first, secondand third helically wound segments being wound in the same longitudinaldirection, wherein a planar surface of the third helically wound segmentfaces a planar surface of the second helically wound segment, whereinthe elongated conductor includes a second return connecting segmentextending substantially the length of the second and third helicallywound segments to connect the second end of the second helically woundsegment to the first end of the third helically wound segment, andincluding dielectric material disposed between facing planar surfaces ofthe second and third helically wound segments.
 43. The multilayerhelical wave filter of claim 28, wherein the wave filter has a Q atresonance wherein the resultant 10 dB bandwidth is at least 10 KHz. 44.The multilayer helical wave filter of claim 43, wherein the wave filterhas a Q at resonance wherein the resultant 10 dB bandwidth is at least100 kHz.
 45. The multilayer helical wave filter of claim 44, wherein thewave filter has a Q at resonance wherein the resultant 10 dB bandwidthis on the order of megahertz and at least 0.5 MHz.
 46. The multilayerhelical wave filter of claim 28, wherein by controlling the dielectrictype, the dielectric constant of the dielectric material may be variedfrom 2 to
 50. 47. The multilayer helical wave filter of claim 28,wherein the primary resonance of the wave filter comprises a pluralityof selected MRI RF pulsed frequencies or frequency ranges.
 48. Themultilayer helical wave filter of claim 28, wherein the wave filterresonates at the selected RF frequency or frequency range and at one ormore of its harmonic frequencies.
 49. The multilayer helical wave filterof claim 28, wherein the first helically wound segment has a differentcross-sectional area than the second helically wound segment.
 50. Themultilayer helical wave filter of claim 28, wherein the first helicallywound segment has a different number of turns than the second helicallywound segment.
 51. The multilayer helical wave filter of claim 28,including electrical insulation for attenuating RF currents in bodyfluids or tissues from degrading the impedance of the wave filter atresonance.
 52. The multilayer helical wave filter of claim 51, whereinthe insulation is contiguous with an overall insulation of theimplantable lead.
 53. The multilayer helical wave filter of claim 52,including an electrically insulative sleeve disposed about the elongatedconductor.